盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.073756323758163759413756933750493756260.10
212.143767203767533767360.01
单位质量响应值RSD%判断
31120.6331032.620.21数据可信
供试品溶液-BXJVV51批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min187689-8768921.29820.753.4821.3020.753.48
281974-8197419.91019.91
383686-8368620.32620.33
490069-9006921.87621.88
585217-8521720.69820.70
683891-8389120.37620.38
10min1150217-15021736.48535.163.0136.5235.193.01
2142185-14218534.53434.57
3138605-13860533.66533.70
4149177-14917736.23236.27
5144147-14414735.01135.05
6144130-14413035.00635.04
15min1184312-18431244.76643.842.0944.8643.942.09
2177397-17739743.08643.18
3175449-17544942.61342.70
4185062-18506244.94845.04
5180049-18004943.73143.82
6180836-18083643.92244.01
20min1210772-21077251.19350.242.1551.3650.412.15
2202641-20264149.21849.38
3201127-20112748.85049.01
4209991-20999151.00351.17
5205279-20527949.85850.02
6211338-21133851.33051.50
30min1247845-24784560.19759.241.4660.4559.491.46
2240531-24053158.42058.67
3240183-24018358.33658.58
4248394-24839460.33060.59
5242524-24252458.90559.15
6244044-24404459.27459.52
45min1282581-28258168.63467.481.3468.9967.831.34
2272565-27256566.20166.54
3275095-27509566.81567.16
4279929-27992967.98968.35
5280056-28005668.02068.37
6276726-27672667.21267.56
60min1303288-30328873.66372.411.8374.1372.871.83
2289801-28980170.38770.84
3298384-29838472.47272.92
4304703-30470374.00774.48
5297278-29727872.20372.66
6295381-29538171.74272.20
90min1331802-33180280.58879.502.4581.1880.082.44
2314871-31487176.47677.05
3326582-32658279.32179.89
4337065-33706581.86782.46
5331847-33184780.59981.18
6321826-32182678.16578.75
120min1348676-34867684.68783.242.3385.4183.962.32
2330661-33066180.31181.01
3343006-34300683.31084.01
4350224-35022485.06385.79
5348136-34813684.55685.27
6335664-33566481.52682.24
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1371590-37159090.25289.261.6391.1290.111.63
2360520-36052087.56488.39
3361191-36119187.72688.57
4375660-37566091.24192.11
5369585-36958589.76590.62
6366428-36642888.99889.85
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.073760033760813762283757143755183759090.08
212.143764373766213765290.04
单位质量响应值RSD%判断
31144.0831015.570.30数据可信
供试品溶液-BXJVV51批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193018-9301822.59020.936.2322.5920.936.23
290904-9090422.07722.08
377825-7782518.90018.90
485191-8519120.68920.69
584246-8424620.46020.46
685911-8591120.86420.86
10min1145634-14563435.36834.242.9335.4134.272.93
2143515-14351534.85434.89
3133461-13346132.41232.44
4141319-14131934.32034.35
5140836-14083634.20334.24
6141085-14108534.26334.30
15min1180950-18095043.94542.013.0844.0442.103.08
2176326-17632642.82242.92
3166100-16610040.33840.42
4170126-17012641.31641.41
5169965-16996541.27741.37
6174374-17437442.34842.44
20min1205160-20516049.82448.132.6649.9948.292.66
2201159-20115948.85349.02
3190348-19034846.22746.38
4195794-19579447.55047.71
5195691-19569147.52547.68
6200945-20094548.80148.96
30min1239071-23907158.06056.622.4358.3156.862.43
2235018-23501857.07657.32
3224656-22465654.55954.79
4230764-23076456.04356.28
5230193-23019355.90456.14
6239065-23906558.05958.30
45min1272032-27203266.06564.772.2566.4165.112.25
2267414-26741464.94365.29
3257009-25700962.41662.74
4263148-26314863.90764.24
5267430-26743064.94765.28
6273254-27325466.36266.70
60min1296128-29612871.91770.672.3672.3871.122.36
2293203-29320371.20671.66
3279291-27929167.82868.25
4286880-28688069.67170.11
5292755-29275571.09871.54
6297772-29777272.31672.77
90min1326201-32620179.22077.762.2779.8078.322.27
2321767-32176778.14378.71
3308245-30824574.85975.40
4318258-31825877.29177.85
5317874-31787477.19877.76
6328751-32875179.83980.41
120min1343128-34312883.33181.922.3084.0482.612.30
2338673-33867382.24982.95
3324740-32474078.86579.53
4334593-33459381.25881.94
5335693-33569381.52582.21
6347073-34707384.28984.99
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1363601-36360188.30387.860.4589.1588.690.46
2363691-36369188.32589.16
3360255-36025587.49088.28
4361379-36137987.76388.58
5359967-35996787.42088.24
6361843-36184387.87688.72
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